Microbial limits for non-sterile chemical drugs, active pharmaceutical ingredients (API) and excipients were released in a new set of guidelines (trial) by China’s Center for Drug Evaluation (CDE) on February 17, 2023. These guidelines are intended to serve as a reference for pharmaceutical companies and industry peers.
The main objective of these guidelines is to enhance the application of quality risk management in product quality control and improve the scientific and rational development of microbial limit standards for non-sterile chemical drugs and raw and auxiliary materials. Several problems were discovered with the current declaration process for non-sterile chemicals, raw and auxiliary materials hence the reason for developing these trial guidelines:
- The first issue is that there is no study of microbial limits in the declaration information and no risk assessment. This means that pharmaceutical companies are not adequately assessing the risks associated with microbial limits and may be missing potential issues with their products.
- The second problem is that the content related to microbial limit testing reflected in the declaration information is not standardized and perfect. This can lead to inconsistencies in testing methods and limit settings, making it difficult to compare results between different products.
- The third issue is that the source of strains and testing methods in the declaration of imported drug registration information is problematic. This means that the data presented in these declarations may not be reliable or accurate, which can have serious consequences for product safety and efficacy.
To address these issues and the uncertain impact they have on drug technical and quality reviews, China’s Center for Drug Evaluation has issued guidelines to guide pharmaceutical companies in standardizing microbial limits for research.
The guidelines provide detailed information on control strategies for:
- microbial limit studies of non-sterile chemicals, raw materials and excipients,
- selection of detection methods and limit setting,
- and production process control.
They also clarify the requirements for microbial limit declaration information, including:
- microbial limit detection methods,
- method applicability test information,
- microbial limit control strategy,
- and the basis for development.
This information should be included in the declaration information and corresponds to chapters 3.2.S.4 and 3.2.P.5 on the development of analytical methods, validation of analytical methods, and the basis for the development of quality standards. In these chapters, studies are to be conducted in full accordance with the requirements of this guideline.
Read the original CDE’s announcement (No.11-2023) on the release of technical review guidelines (trial) for microbial limits on non-sterile chemical drugs and active pharmaceutical ingredients.
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